Ohio Admin. Code 4729:5-23-01 - Limited facilities - definitions
As used in Chapter 4729:5-23 of the Administrative Code:
(A)
"Limited facility" means a facility licensed as a
limited category II or limited category III terminal distributor of dangerous
drugs in accordance with section
4729.54 of the Revised Code
where drugs are possessed on-site for administration, dispensing, or personally
furnishing. The facility shall comply with all requirements set forth in this
chapter.
(1)
A
limited facility includes any of the following:
(a)
Dog trainers
affiliated with an Ohio law enforcement agency;
(b)
Home health care
providers, including those offering in-home services;
(c)
Hospice care
providers of in-home services;
(d)
Physical therapy
providers;
(e)
Teaching institutions; and
(f)
Any other
facility as determined by the board.
(2)
A limited
facility does not include any of the following:
(a)
Non-limited
facilities as defined in Chapter 4729:22 of the Administrative Code;
or
(b)
Any other person or facility licensed as a terminal
distributor of dangerous that is specifically defined and required to comply
with security, control and record keeping requirements of another chapter of
this division (EMS organization, pain management clinic, animal shelter,
etc.).
(3)
A limited facility shall submit an application for
licensure that includes all the following:
(a)
A completed
application;
(b)
A list of the controlled substances and dangerous
drugs, known as a drug list, that may be possessed and administered by a
limited facility, expressed in standard dose units, signed by the responsible
person; and
(c)
The fee for the appropriate category of
licensure.
(4)
A limited facility may only possess those controlled
substances and dangerous drugs that are on the drug list submitted to the board
pursuant to paragraph (A)(3)(b) of this rule and only at locations licensed by
the state board of pharmacy. The responsible person may modify the drugs that
may be possessed and administered by the limited facility by submitting a new
drug list to the state board of pharmacy in a manner determined by the
board.
(B)
"Controlled substance" has the same meaning as in
section 3719.01 of the Revised
Code.
(C)
"Dangerous drug" has the same meaning as in section
4729.01 of the Revised
Code.
(D)
"Law enforcement officer" has the same meaning as
21
CFR 1300.05 (10/09/2014).
(E)
"Licensed health
professional authorized to prescribe drugs" or "prescriber" has the same
meaning as in rule
4729:5-1-02 of the
Administrative Code but shall be limited to a prescriber practicing within the
prescriber's applicable scope of practice.
(F)
"Personal
supervision" means the person specified in rule shall be physically present at
the licensed location to deter and detect the diversion of dangerous
drugs.
(G)
"Personally furnish" or "personally furnishing" means
the final association of a drug with a patient by a prescriber prior to the
distribution to a patient for use outside the prescriber's practice setting. A
prescriber at a limited facility who personally furnishes a dangerous drug
shall comply with the requirements of rule
4729:5-19-02 of the
Administrative Code.
(H)
(1)
"Positive
identification" means a method of identifying a person that does not rely on
the use of a private personal identifier such as a password, but must use a
secure means of identification such as the following:
(a)
A manual
signature on a hard copy record;
(b)
A magnetic card
reader;
(c)
A bar code reader;
(d)
A biometric
method;
(e)
A proximity badge reader;
(f)
A board approved
system of randomly generated personal questions;
(g)
A printout of
every transaction that is verified and manually signed within a reasonable
period of time by the individual who performed the action requiring positive
identification. The printout must be maintained for three years and made
readily retrievable; or
(h)
Other effective methods for identifying individuals
that have been approved by the board.
(2)
A method relying
on a magnetic card reader, a bar code reader, a proximity badge reader, or
randomly generated questions for identification must also include a private
personal identifier, such as a password, for entry into a secure mechanical or
electronic system.
(I)
"Readily
retrievable" means that records maintained in accordance with this chapter
shall be kept in such a manner that, upon request, they can be produced for
review no later than three business days to an agent, officer or inspector of
the board.
(J)
"Responsible person" has the same meaning as defined in
rule 4729:5-2-01 of the
Administrative Code and is responsible for the supervision and control of
dangerous drugs as required in division (B) of section
4729.55 of the Revised Code,
adequate safeguards as required in division (C) of section
4729.55 of the Revised Code,
security and control of dangerous drugs and maintaining all drug records
otherwise required.
Notes
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.54
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